Source – Moderna
On July 3, 2023 Moderna announced the submission of a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine. This new vaccine encodes the spike protein for the XBB.1.5 sublineage of SARS-CoV-2.
“We are proud to announce this filing for our updated COVID-19 vaccine and continue to support the European Union in protecting citizens against COVID-19. Our preliminary clinical testing showed that our updated COVID-19 vaccine is effective in generating an immune response against the current XBB variants of concern, and we believe it will play a critical role in protecting against severe disease and hospitalization. We look forward to working with the EMA to bring our updated vaccine to people across the European Union.”
– Stéphane Bancel, Chief Executive Officer of Moderna
Moderna’s application is based on guidance from the European Centre for Disease Prevention and Control (ECDC) and the EMA, which recommended updating COVID-19 vaccines to a monovalent XBB.1.5 composition. This aligns with the recommendations of other regulators and global public health agencies. Additionally, Moderna has generated preliminary clinical data for its monovalent XBB.1.5 vaccine candidate, demonstrating an immune response against XBB descendent sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2.
Moderna is currently in the process of submitting data to regulators worldwide to advance its updated COVID-19 vaccine, with the aim of making it available for the autumn/winter vaccination season. The company has recently filed with the US Food & Drug Administration, Health Canada, and other health authorities.